In the past two years, we have informed public policy debates on numerous and varied issues. Some notable examples include:

In the United States:

• Health Care Reform: Merck supports health care system reform in the U.S. that will ensure affordable access to health care coverage for all Americans. Without coverage, millions of Americans are denied access to needed health care including prescription medicines and other basic services. We believe reforms should rely on market-based competition to improve quality, control costs, and continue to encourage the innovation that has made the U.S. system so remarkable. Merck also supports proposals to reduce health spending by increasing competition around health outcomes for patients, and by changing the tax code to remove the incentives for unlimited health care spending. Furthermore, we believe all individuals should be required to purchase health insurance, every employer should provide insurance or pay into a fund, and the government should provide subsidies or insurance for those who cannot afford it. Merck supports promoting greater efficiency and enhanced quality of care in the health care system through increased research and public dissemination of cost and quality information, including increased price transparency at the point of service, as well as enhanced use of health information technology — such as electronic personal health records. Additional information on Merck's position can be found here.
• Biosimilars: Merck supports legislation that would provide an abbreviated regulatory pathway for approval of biosimilars. We believe such an abbreviated approval pathway must assure patient safety and preserve incentives that encourage continued biologics innovation. Merck believes that the Food and Drug Administration (FDA) must have the flexibility to require the appropriate safety and efficacy studies for any biologic product under regulatory review in the United States. Recognizing that the biologics market will likely never resemble today's world of generic small molecule drug products, Merck believes the cost savings that could be realized through the introduction of biosimilar products may provide additional resources to fund research, development, and payment of new innovative products for patients who need them. Merck also believes it is essential for biologics to be granted a substantial period of data and market exclusivity needed to preserve an environment that promotes the discovery of innovative therapies, and that legislation should establish a fair, transparent and workable system for all parties to promptly resolve any patent litigation issues.
• Transparency: Supported the Physician Payments Sunshine Act legislation (PDF*). Merck supports the creation of a uniform, national program for disclosing certain financial relations between industry and physicians. We believe that such a program, implemented in consultation with industry and the physician community, could provide helpful information to the public.
• Anti-Counterfeiting: Supported efforts to strengthen anti-counterfeiting laws, including the Safeguarding America's Pharmaceuticals Act.
• Vaccine Funding: Supported increased federal and state funding for vaccine programs.
• Comparative Effectiveness Research: Merck continued to support legislation creating an independent entity that conducts science-based comparative effectiveness research as a means to achieve greater value and efficiencies in the U.S. health care system. For more information, click here.
• Importation: Opposed legislation that would legalize the importation of pharmaceuticals from certain industrialized countries. Merck opposes importation because we believe it would compromise public trust in the manufacture and distribution of our medicines and harm the incentives that encourage Merck and other research-based companies to conduct the high-risk research and development that leads to new medicines. Merck medicines in other countries cost less than the same medicines in the United States for several reasons. The most significant is that many foreign governments artificially reduce our prices and sales through direct and often arbitrary government price controls and by denying their citizens access to the newest medicines. For more information, click here.
• Non-interference: Opposed legislation that would require the U.S. Secretary of the Department of Health and Human Services (HHS) to interfere in private sector negotiations between drug manufacturers and the private prescription drug plans that provide Medicare beneficiaries with their drug benefit. The Congressional Budget Office, the Department of HHS and private economists have stated that the removal of the non-interference provision would generate negligible savings and the private sector design of the new Medicare prescription drug coverage is more effective in reducing cost to beneficiaries and the government. For more information, click here.
• Marketing Practices: Opposed state legislative proposals that would unnecessarily regulate and/or restrict the ability of Merck professional representatives to interact with health professionals. Rather than pass different regulations in multiple states, Merck supports strong provisions in industry codes of conduct that govern the interaction of pharmaceutical representatives with health professionals. In 2008, we supported strengthening the Pharmaceutical Research and Manufacturers of America (PhRMA) Code concerning the training and conduct of company sales representatives. Merck's rigorous compliance program ensures that all Company sales representatives receive comprehensive training about applicable laws, regulations and industry codes of practice. Merck supports the creation of a uniform, national program for disclosing certain financial relations between industry and physicians.

Internationally:

• Health Care System Reform: Promoted health care system reform, including initiatives to address pricing and reimbursement conditions for innovative products in the European Union, Asia Pacific and Latin America. In Europe, for example, Merck supports many of the policies advocated by the European Federation of Pharmaceutical Industries (EFPIA).
• Biosimilars: Supported the adoption of regulatory guidelines for biosimilar products in many international markets, including Japan, Australia, Korea, Taiwan, Malaysia and Mexico.
• Intellectual Property Protection: Supported strong intellectual property protections in Europe, Asia Pacific and Latin America. In 2008, our educational efforts have focused on preventing issuance of compulsory licenses and strengthening data protection.
• Trade: Advanced increased access to innovative medicines in many countries by supporting bilateral and multilateral trade agreements promoting more open and transparent markets. For example, Merck supported free trade agreements with a significant number of countries and regions, such as, Chile and Central America.
• Anti-Counterfeiting: Merck is working with EFPIA and other organizations to raise awareness about the serious public health risks posed by counterfeit medicines, and to promote regulatory changes to enhance public safety. We believe the draft EU directive on counterfeiting, which includes the development of a standardized system to identify medical products as they move through the supply chain, is a balanced approach and represents a significant step forward.
• Promoting Innovation: Merck Frosst is a leading participant in creating an environment that supports the development of a robust life sciences sector in Canada. One example of our efforts is partnering in the conceptualization and development of the Centre for the Advancement of Health Innovation (CAHI). This Centre, which brings together researchers, biotech companies, pharmaceutical companies and governments, will be examining the various elements of health innovation policy and the opportunities they offer for improving the performance of Canada's health innovation system.
• Health Technology Assessment: Supported improvements to Health Technology Assessment (HTA) processes in the United Kingdom through active participation in industry and government collaboration around access to medicines. This was accomplished through senior executive membership in the ABPI's Access Strategy Group and HTA User Groups in England and Scotland.
• Health Care Delivery Systems: Supported working with global health leaders on policies and projects to improve health care delivery systems in the developing world. See Merck's Program on Pharmaceutical Policy Issues for examples.
• Competitiveness: Promoted policies that would support innovation and competitiveness in Mexico and other Latin America countries. For example, Merck supports the Global Initiative of the Council on Competitiveness.
• Regulatory Reform: Supported systemic changes to improve the quality and timing of regulatory review in Japan.

Advocacy Performance Data Summary 2005-2008

Merck KPIs	2008	2007	2006	2005
Corporate political contributions (US, CAN, AUS) US$*	US:$597,775 AUS:$5,040 CAN:$30,965	US:$470,625 AUS:$19,195 CAN:$58,396	US:$611,975 AUS:$20,292 CAN:$45,765	US:$337,140 AUS:$12,137 CAN:$46,700
Portion of dues that the major U.S.- based trade associations report to us as being used for advocacy and/or political activities in the U.S.(U.S.$) where dues are > $ 50,000**	$6.8 million paid to 8 groups	$6.9 million paid to 8 groups	n/a	n/a
Compliance with political contribution evaluation criteria used by the Center for Political Accountability	All 11 principles	10 out of 11 principles	n/a	n/a

• Beginning in 2009, Merck expanded disclosure of corporate political campaign contributions to Australia and Canada, the only other countries where Merck provides such contributions.
• In 2008, Merck began disclosing on our website the portion of dues that major U.S.-based trade associations report to us as being used for advocacy and/or political activity purposes where dues are >$50,000.
• In 2009, Merck is including in its CR report a statement on actions taken to ensure adherence to ethical business practices related to corporate political spending, as recommended in the model code of conduct from the Center for Political Accountability. 

---

*Totals reflect corporate contributions; employee contributions through the Merck PAC are not included. Political contributions in the United States, which are for state candidates, are always much greater in even-numbered calendar years, because that is when the overwhelming number of states hold their elections for state legislatures and governors.

** Because the U.S. tax law that requires this reporting does not apply outside the United States, trade associations that are not subject to this do not provide break-outs of lobbying expenditures from membership dues. Thus, at this time, Merck is unable to report these data for such lobbying expenses in other countries.

The content on this page was last modified on September 15, 2009.

Merck & Co., Inc., Whitehouse Station, NJ, USA, and Schering-Plough Corporation, Kenilworth, NJ, USA, are now one company. We have combined our global operations under the name Merck & Co., Inc. We are working to update our corporate responsibility Web site to reflect our new, combined, global organization.